Dimethyl 2-aminoterephthalate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: well performed GLP and OECD guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl 2-aminoterephthalate

EC Number:

226-364-2

EC Name:

Dimethyl 2-aminoterephthalate

Cas Number:

5372-81-6

Molecular formula:

C10H11NO4

IUPAC Name:

1,4-dimethyl 2-aminobenzene-1,4-dicarboxylate

Constituent 2

Reference substance name:

dimethyl-2-aminoterephthalate

IUPAC Name:

dimethyl-2-aminoterephthalate

Details on test material:

- Name of test material (as cited in study report): Aminoterephthalsäuredimethylester

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae
- Age at study initiation: about 3 - 5 months
- Weight at study initiation: 2.1-2.2 kg
- Housing: in fully air-conditioned rooms, separate cages
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet - rabbits, ad libitum
- Water (e.g. ad libitum): from automatic water dispensers, ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ±20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: Polyethylene glycol 400

Controls:

not required

Amount / concentration applied:

Each animal was treated with 0.5 g test item mixed with 0.3 ml polyethylene glycol 400

Duration of treatment / exposure:

The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Observation period:

Examinations of the skin took place after 30 - 60 min as well as 24, 48, 72 hours after removal of the patches.

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: # 176, 177, 178 each

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (erythema) at any time

Results 2

Irritation parameter:

edema score

Basis:

other: # 176, 177, 178 each

Time point:

other: mean of 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no signs of irritation (edema) at any time

Irritant / corrosive response data:

Throughout the whole study no irritations were observed at the treated skin of the animals.

Other effects:

no other effects reported

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Based on the findings in this test the test substance is neither skin irritating nor skin corrosive.

Executive summary:

Aminoterephthalsäuredimethylester was tested for skin irritating properties according to OECD 404. Following this protocol 500 mg test substance mixed with 0.3 ml polyethylene glycol 400 were applied to the shaved skin of 3 New Zealands White rabbits. After 4 h exposure time the semioccolusive patch was removed. Residual substance was removed with warm tap water. Animals were examined for signs of skin irritation/corrosion at 30 - 60 min, 24, 48 and 72 hours after removal of the patches. Mean scores (mean of 24, 48, 72 h) were calculated for oedema and erythema for each rabbit.

Based on the findings in this test the test substance is neither skin irritating nor skin corrosive.